The development of guidance and new templates to improve Participant Information & Consent Forms
Timeline: March 2021 – December 2022
- The majority of the sector use the 2012 Participant Information & Consent Forms (PICF) templates on the NHMRC website.
- These templates produce long and complex PICFs (often 25+pages).
- Feedback and research indicates that these are not what participants want or need to make an informed decision to participate in a clinical trial.
- In 2016 a working group developed a new National PICF template for interventional studies, however uptake and engagement was limited due primarily to the new template not receiving endorsement from the NHMRC.
- There is a common view that the NHMRC templates need a significant overhaul to create shorter, less complex, more participant friendly version.
- CT:IQ has initiated a sector-wide PICF Innovation project to address this issue.
The sector uses the new nationally consistent, simplified, and more respectful PICF template for the written communication of participant information about clinical research which enables participants to make an informed consent decision
- Develop a simplified, participant friendly national PICF template
- Demonstrate critical mass/intention to adopt from the sector in order to seek NHMRC endorsement
- Obtain NHMRC endorsement replacing the existing 2012 templates on their website
This is a big project so defining the scope is important. This project will most likely lead to follow on projects.
|IN SCOPE||OUT OF SCOPE|
|The PICF as part of the informed consent process for participation in a clinical research study||Reviewing the end-to-end consent process
(e.g. discussions with investigators, method of obtaining signatures)
|Developing the written content for a new PICF template||Determining the mode of delivery or specific platforms used for the written content, it is up to the user to determine if they use paper or electronic means
(e.g. using REDCap to conduct eConsent)
|Design that PICF template so that it can be used across all types of studies in clinical research*||Developing a suite of templates for different types of studies|
|Exploring the use of technology to enhance/simplify the written PICF template (e.g. collapsible forms, linking to more detailed information). |
However, funding will need to be sourced for any major external spend
|Development of eConsent multimedia tools e.g. videos, audio|
* This will be further defined as the project progresses. We are aiming to have the minimum number of templates (goal is for one) that can be used in the greatest number of applications. Currently there are 12 NHMRC templates.
A project team comprising over 35 people from CT:IQ member organisations has been established, meeting fortnightly, to undertake this exciting project.